ULTRA PRESERVE WITH ALOE VERA (GREEN) NATURAL RUBBER LATEX EXAMINATION GLOVE MADE FROM ALLOTEX AN ENZYME TREATED NATURAL

K021007 · Tillotson Healthcare Corp. · LYY · Jul 5, 2002 · General Hospital

Device Facts

• Record ID: K021007
• Device Name: ULTRA PRESERVE WITH ALOE VERA (GREEN) NATURAL RUBBER LATEX EXAMINATION GLOVE MADE FROM ALLOTEX AN ENZYME TREATED NATURAL
• Applicant: Tillotson Healthcare Corp.
• Product Code: LYY · General Hospital
• Decision Date: Jul 5, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The Ultra Preserve With Aloe Vera (Green) Examination Glove is "a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.". (21CFR 880.6250).

Device Story

Disposable natural rubber latex examination glove; acts as physical barrier against body fluids and bloodborne pathogens. Manufactured using Allotex (enzyme-treated latex) to reduce protein content; inner surface treated with Aloe Vera; green pigment added. Tensile properties allow hand conformation for medical procedures. Used in clinical settings by healthcare professionals. Provides protection against contamination; enzyme treatment and low particulate levels benefit users with potential latex sensitivity.

Clinical Evidence

No clinical data. Safety and effectiveness supported by non-clinical bench testing including water tightness (ASTM D5151-99), residual protein (ASTM D5712-99), residual particulate (ASTM D6124-00), and antigenic protein (ASTM D6499-00). Biocompatibility testing included rabbit irritation and guinea pig sensitization studies.

Technological Characteristics

Natural rubber latex treated with enzymes (Allotex). Inner surface coated with Aloe Vera. Green pigment. Complies with ASTM D3578-00/00a and ASTM D5151-99. Protein content <= 200 micrograms/glove; total particulate <= 15 mg/glove. Non-sterile, disposable, powder-free.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand to prevent cross-contamination between patient and examiner. Suitable for use where healthcare worker or patient allergic sensitivity to latex proteins may be a factor.

Regulatory Classification

Identification

A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.

Predicate Devices

• Ultra Care Natural Rubber Latex Examination Gloves Made from Allotex (K002718)
• Ultra Care (GREEN) Natural Rubber Latex Examination Gloves (K982505)
• CymunVera Powder Free GREEN Natural Rubber Latex Exmination Gloves Lined with ALOE VERA (K013286)

Submission Summary (Full Text)

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510(k) Sub. - Ultra Preserve With Aloe Vera (Green) Natural Rubber Latex Examination Glove Made from Allotex an enzyme treated natural rubber latex with a Protein Content Claim of 200 micrograms or less with 15 milligrams or less of Total Particulate per Glove. Submission Date: April 2002 510(k) Number:

[TAB #13]

### 5 2002 JUL

K021007

Attachment #11

Summary of 510(k) Submission

A. INFORMATION

- SUBMITTER'S ﺎﺳﻢ NAME:
TILLOTSON HEALTHCARE CORPORATION

Bedford, NH 03110 U.S.A.

360 Route 101

[phone]

F.W. Perrella

April 2002

| ADDRESS: |
|----------|
|----------|

TELEPHONE NUMBER:

CONTACT PERSON:

DATE SUMMARY PREPARED:

2. NAME OF DEVICE

TRADE OR PROPRIETARY NAME:

Ultra Preserve With Aloe Vera (Green) Natural Rubber Latex Examination Glove Made from Allotex® an enzyme treated natural rubber latex with a Protein Content Claim of 200 micrograms or less with 15 milligrams or less of Total Particulate per Glove.

| COMMON OR USUAL NAME: | |
|-----------------------|--|
|-----------------------|--|

Examination Glove

CLASSIFICATION NAME:

NAME, NUMBER

Examination Glove

3. PREDICATE DEVICE IDENTIFICATION

a. Ultra Care Natural Rubber Latex Examination Gloves Made from Allotex® an enzyme treated natural rubber latex with a Protein Content Claim of 200 micrograms or less with 15 milligrams or less of Total Particulate per Glove. (K002718) b. Ultra Care (GREEN) Natural Rubber Latex Examination Gloves (K982505)

c. CymunVera Powder Free GREEN Natural Rubber Latex Exmination Gloves Lined with ALOE VERA (K013286)

#### 4. DESCRIPTION OF DEVICE

- HOW THE DEVICE FUNCTIONS: ટ્વ. Natural Rubber Latex films form a barrier to body fluids and bloodborne pathogens.
- SCIENTIFIC CONCEPTS THAT FORM THE BASIS FOR THE DEVICE: b. The latex rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure.
- ﻥ ﻧ PHY SICAL AND PERFORMANCE CHARACTERISTICS SUCH AS DESIGN,

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## MATERIALS

## AND PHYSICAL PROPERTIES:

Natural Rubber Latex is known to create a barrier to bloodborne pathogens and and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The leaching process removes traces of chemical accelerants that may be chemically irritating. The glove is manufactured in accordance with the requirements of ASTM D3578-00 and ASTM D5151-99 requirements.

- STATEMENT OF INTENDED USE, INCLUDING DESCRIPTION OF THE DISEASES OR 5. CONDITIONS THAT THE DEVICE WILL ADDRESS
This is a disposable device, intended for medical purposes, that is worn on the examiner's hand to prevent contamination between patient and examiner. Examination gloves with protein content labeling are suitable in situations where healthcare worker or patient allergic sensitivity may be a factor.

- EXPLANATION OF SIMILARITIES OR DIFFERENCES TO PREDICATE DEVICE ર. The modified product has a raw material change whereby the inner surface of the glove is treated with Aloe Vera and the natural rubber latex is treated with Green pigment compared to the predicate product.
#### B. IF THE DECISION BASED ON PERFORMANCE DATA DISCUSSION OF NON-CLINICAL TESTS 1.

| SPECIFICATION | PROPOSED | PREDICATE |
|---------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Same as predicate<br>but with a Green<br>color and Aloe Vera<br>labeling claims. | Ultra Care synthetic inner coating with no<br>starch donning powder added with Protein<br>and Particulate Content labeling Claims and<br>Made from Allotex an enzyme treated<br>natural rubber latex claim. (K002718) |
| | Same Green color as<br>predicate but with<br>Aloe vera, Protein<br>and particulate<br>Content labeling<br>Claims and Made<br>from Allotex an<br>enzyme treated<br>natural rubber latex<br>claim | Ultra Care synthetic inner coating with no<br>starch donning powder added and with a<br>powder content labeling claim and GREEN<br>colorant labeling claim. (K982505) |
| | Same Aloe Vera<br>containing as<br>predicate but with<br>Made from Allotex<br>an enzyme treated<br>natural rubber latex<br>claim | Cymun Vera Green synthetic inner coating<br>with no starch donning powder added and<br>with an Aloe Vera content labeling claim and<br>Green colorant labeling claim. (K013286) |

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510(k) Sub. - Ultra Preserve With Aloe Vera (Green) Natural Rubber Latex Examination Glove Made from Allotex® an enzyme treated natural rubber latex with a Protein Content Claim of 200 micrograms or less with 15 milligrams or less of Total Particulate per Glove. Submission Date: April 2002 510(k) Number: K K ASTM D3578-99 ASTM D3578-00a

| PERFORMANCE<br>STANDARDS | ASTM D3578-00a | ASTM D3578-99 |
|---------------------------------|----------------|---------------|
| WATER TIGHTNESS | ASTM D5151-99 | ASTM D5151-99 |
| RESIDUAL PROTEIN | ASTM D5712-99 | ASTM D5712-99 |
| RESIDUAL PARTICULATE | ASTM D6124-00 | |
| ANTIGENIC PROTEIN | ASTM D6499-00 | |
| DISCUSSION OF CLINICAL<br>TESTS | | |
| SPECIFICATION<br>SAFETY | PROPOSED | PREDICATE |
| RABBIT IRRITATION | | PASS |
| GUINEA PIG SENSITIZATION | | PASS |

DEDEODA (ANDD

2.

- CONCLUSIONS DRAWN FROM NONCLINICAL AND CLINICAL TESTS THAT DEMONSTRATE 3. SAFETY EFFECTIVENESS, AND PERFORMANCE =/> PREDICATE PRODUCT
The Ultra Preserve, Examination Glove has been carefully compared to legally marketed devices in the 510(k). The data summaries indicate that the proposed product meets or exceeds acceptable scores for the predicate product in nonclinical tests, and satisfies the requirements for a safe and effective, green, aloe vera, no starch donning powder added with 15 milligrams or less of total particulate with protein content labeling claim (200 micrograms or less) per glove and made from Allotex an enzyme treated natural rubber lates claim medical glove

Pursuant to 21 C.F.R. 807.87 ( j ), I, F.W. Perrella, Ph.D., Vice President R&D certify that to the best of my knowledge and belief and based upon the data and information submitted to me in the course of my responsibilities as the V.P. R&D for TILLOTSON HEALTHCARE CORPORATION, and in reliance thereupon, the data and information submitted in this of the substantial equivalence of this device have been knowingly omitted from this Submission.

F.W. Perrella, Ph.D. Vice President R&D

R.M. Panella

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

JUL 5 2002 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Frank W. Perrella Vice President, Research and Development Tillotson Healthcare Corporation 360 Route 101 Bedford, New Hampshire 03110

Re: K021007

Trade/Device Name: Ultra Preserve with Aloe Vera (Green) Natural Rubber Latex Examination Gloves made from Allotex® an enzyme treated natural rubber latex with a Protein Content Labeling Claim ( 200 Micrograms or Less ) with 15 Milligrams or Less of Total Particulate per Glove Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: June 14, 2002 Received: June 14, 2002

Dear Mr. Perrella:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Perrella

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Runner

Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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- 3.0 Indications for Use Statement: Include the following or equivalent Indications for Use page. The information, data and labeling claims in the entire the 510(k) submission must support and agree with the Indications for Use statement.
# INDICATIONS FOR USE

| Applicant: | Tillotson Healthcare Corporation |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 5 10(k) Number (if known):* | K021007 |
| Device Name: | Ultra Preserve With Aloe Vera (Green) Natural Rubber Latex Examination Glove Made from Allotex ^® an enzyme treated natural rubber latex with a Protein Content Claim of 200 micrograms or less with 15 milligrams or less of Total Particulate per Glove. |

Indications For Use:

The Ultra Preserve With Aloe Vera (Green) Examination Glove is "a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.".

(21CFR 880.6250).

Qim Sahn

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital, Devices 510(k) Number

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE)

Prescription Usc OR Over-The-Counter Per 21 CFR 801.109 (Optional Format 1-2-96)